search
Back to results

Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conductance catheterization
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Male or females between 18-75 years of age
  • NYHA Class III-IV heart failure at the time of MEGA deployment
  • Stage C-D systolic heart failure
  • Non-ischemic cardiomyopathy
  • Preserved right ventricular function defined by 2D-echocardiography
  • Clinically indicated left and right heart catheterization and MEGA-IABP placement
  • Clinically indicated MEGA-IABP support for 12 hours minimum

Exclusion Criteria:

  • Ischemic cardiomyopathy
  • Active myocardial ischemia or acute coronary syndrome
  • Severe peripheral vascular disease
  • Severe aortic or mitral valve insufficiency
  • Severe aortic or mitral valve stenosis
  • Right ventricular failure
  • Inability to tolerate left and right heart catheterization
  • Severe hemodynamic instability defined as a systolic BP <80mmHg despite vasopressor/inotropic support
  • Sustained ventricular tachycardia (>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours
  • Pacemaker dependent rhythm
  • Left ventricular thrombus
  • Rapid atrial fibrillation (HR>120 bpm)
  • Unable to provide informed consent
  • Pregnancy

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

IABP recipient

Control

Arm Description

Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.

Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.

Outcomes

Primary Outcome Measures

Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.
We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.

Secondary Outcome Measures

Full Information

First Posted
March 27, 2014
Last Updated
April 25, 2017
Sponsor
Tufts Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT03001674
Brief Title
Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure
Official Title
Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to develop normative hemodynamic data (means and standard deviations) for the intra-aortic balloon pump (IABP) using pressure-volume loop and 3D-echocardiographic analyses.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IABP recipient
Arm Type
Experimental
Arm Description
Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.
Arm Title
Control
Arm Type
Experimental
Arm Description
Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
Intervention Type
Device
Intervention Name(s)
Conductance catheterization
Intervention Description
CD Leycom Conductance Catheter
Primary Outcome Measure Information:
Title
Impact of Intra-aortic Balloon Pump Activation on Left Ventricular Stroke Work.
Description
We will be measuring left ventricular stroke work using a conductance catheter before and immediately after activation of an intra-aortic balloon pump (IABP). Left ventricular stroke work is quantified as the product of left ventricular pressure and volume. Conductance catheters are the primary method available for clinical measurement of left ventricular volume and pressure.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or females between 18-75 years of age NYHA Class III-IV heart failure at the time of MEGA deployment Stage C-D systolic heart failure Non-ischemic cardiomyopathy Preserved right ventricular function defined by 2D-echocardiography Clinically indicated left and right heart catheterization and MEGA-IABP placement Clinically indicated MEGA-IABP support for 12 hours minimum Exclusion Criteria: Ischemic cardiomyopathy Active myocardial ischemia or acute coronary syndrome Severe peripheral vascular disease Severe aortic or mitral valve insufficiency Severe aortic or mitral valve stenosis Right ventricular failure Inability to tolerate left and right heart catheterization Severe hemodynamic instability defined as a systolic BP <80mmHg despite vasopressor/inotropic support Sustained ventricular tachycardia (>10 beats) within 24 hours and/or ventricular fibrillation within 24 hours Pacemaker dependent rhythm Left ventricular thrombus Rapid atrial fibrillation (HR>120 bpm) Unable to provide informed consent Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Navin Kapur, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Hemodynamic Study of Balloon Counterpulsation in Advanced Heart Failure

We'll reach out to this number within 24 hrs